🇦🇺Australia

Cost of Poor Quality from CAPA Failures

1 verified sources

Definition

Customer complaint investigations trigger CAPA under TGA PRAC procedure, requiring detailed CAPA documentation to prevent reoccurrence. Failures result in recalls, which incur direct costs including product disposal, refunds, and regulatory reporting.

Key Findings

  • Financial Impact: AUD 50,000+ per major recall event (rework, refunds, disposal); 2-5% of revenue in quality failures for non-compliant manufacturers
  • Frequency: Per customer complaint or non-conformance leading to recall
  • Root Cause: Manual CAPA processes fail to identify root causes, leading to recurring issues and TGA-mandated recalls

Why This Matters

The Pitch: Personal care product manufacturers in Australia 🇦🇺 waste AUD 50,000+ per recall event on investigations and corrections. Automation of complaint investigation and CAPA eliminates this risk.

Affected Stakeholders

Quality Manager, Manufacturing Director, Compliance Officer

Deep Analysis (Premium)

Financial Impact

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Current Workarounds

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Methodology & Sources

Data collected via OSINT from regulatory filings, industry audits, and verified case studies.

Evidence Sources:

Related Business Risks

ACCC Fines for Consumer Complaints

AUD 1.1M to AUD 50M per ACCC infringement (max penalty 10x benefits or AUD 10M); typical AUD 100,000+ settlements

Rework and Waste in CAPA Processes

AUD 20-40 hours per CAPA investigation (quality staff at AUD 100/hr); 5-10% batch value in scrap/rework

Cost of Poor Quality in Batch Production

AUD 20,000-100,000 per year in rework, disposal, and stability testing for SMEs (2-5% of production costs based on industry standards)

Capacity Loss from Quality Rework

AUD 10-40 hours per rework incident (AUD 500-2,000 at AUD 50/hr labor + overhead)

GMP Non-Compliance Audit Failures

AUD 5,000-20,000 per failed GMP audit (re-audit fees, consultant costs, production halts)

AICIS Non-Compliance Fines

Fines up to $10 million AUD for corporations; product recalls and market withdrawal.

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